How cranial helmet outcomes relate to parents' expectations and satisfaction
Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants
This project sees if changes in infants' head shape after wearing a custom cranial remolding orthosis (head‑shaping helmet) match parents' expectations and affect how satisfied they feel.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 3 Months to 18 Months |
| Sex | All |
| Sponsor | Gulhane School of Medicine Academic / other |
| Locations | 1 site (Ankara, Keçiören) |
| Trial ID | NCT07356401 on ClinicalTrials.gov |
What this trial studies
This observational study follows infants with positional cranial deformities who receive a custom cranial remolding orthosis and records standardized cranial measurements before and after the treatment period to quantify morphological change. Parents complete the Treatment Expectation Questionnaire (TEX‑Q) before helmet therapy begins and the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) at the end of treatment. The primary analysis examines relationships between objective head‑shape change and parental expectation and satisfaction scores, with secondary analyses exploring whether baseline expectations or degree of correction predict satisfaction.
Who should consider this trial
Good fit: Infants with positional cranial deformities (plagiocephaly, brachycephaly, or asymmetrical head shape) who are prescribed and complete treatment with a custom cranial remolding orthosis and whose caregivers can complete the questionnaires are ideal candidates.
Not a fit: Infants with neurological disorders, genetic syndromes, prior cranial surgery, those treated with non‑custom or prefabricated orthoses, or cases with incomplete pre/post measurements or caregivers unable to complete questionnaires are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians set more realistic expectations, improve family counseling, and guide device choice and follow-up for infants needing cranial remolding orthoses.
How similar studies have performed: Prior studies show custom cranial orthoses reliably produce measurable head‑shape improvements, but links between objective correction and parental expectations or satisfaction are less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants diagnosed with positional cranial deformities (e.g., plagiocephaly, brachycephaly, or asymmetrical cranial shape) * Infants who received cranial remolding orthosis treatment * Use of a custom-made cranial remolding orthosis * Availability of pre-treatment and post-treatment cranial measurements * Parents or legal guardians who provided informed consent and were able to complete expectation and satisfaction questionnaires * Infants who completed the planned cranial remolding orthosis treatment and follow-up period Exclusion Criteria: * Infants with neurological disorders, genetic syndromes, or congenital conditions affecting cranial growth * Infants who underwent previous cranial surgery or other cranial interventions * Infants who received non-custom-made or prefabricated cranial orthoses * Incomplete clinical records or missing pre- or post-treatment cranial measurements * Parents or caregivers unable to complete the questionnaires due to language or cognitive limitations * Infants with a diagnosis of microcephaly or macrocéphaly.
Where this trial is running
Ankara, Keçiören
- University of Health Sciences Gülhane Faculty of Health Sciences — Ankara, Keçiören, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Güllü AYDIN YAĞCIOĞLU, Asst. Prof
- Email: gulluaydin23@gmail.com
- Phone: +905536140823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.